Hip Replacement ArthroplastyNCT03505580
AMIStem-H Radiological Assessment
An observational study of Hip Replacement Arthroplasty, run by Medacta International SA at 2 sites in France.
Trial summary
The purpose of this study is to evaluate radiological performance of the cementless femoral stem AMIStem H at 1 and 5-year follow-up. All the patients operated at the investigational sites between April 2009 and April 2012 will be reviewed at 1, 5 and 10 year according to standard practice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Replacement Arthroplasty
- How many people
- 500 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2013to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All the patients who undewent total hip arthroplasty with AMIStem-H cementless femoral stem at the investigational sites between April 2009 and April 2012
Who may be able to join
- patients who underwent total hip arthroplasty at the investigational sites between April 2009 and April 2012
- patients bearing an AMIStem-H cementless femoral stem
Who cannot join
- patients who refuse to give consent for the treatment of data
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique du Cèdre
Bois-Guillaume, 76230
Clinique Paris V
Paris, France, 75005
About this study
Official title: Etude rétrospective et Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la sécurité de l'Implant AMIStem
The purpose of this study is to evaluate radiological performance of the cementless femoral stem AMIStem H at 1 and 5-year follow-up.
All the patients operated at the investigational sites between April 2009 and April 2012 will be reviewed at 1, 5 and 10 year according to standard practice
- Conditions
- Hip Replacement Arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of radiolucencies
Measured: 5 years
Secondary outcomes (4)
correlation between the presence of radiolucencies and patient/implant characteristics
Measured: 5 years, 10 years
evaluation of radiolucent lines progression
Measured: 1 years, 10 years
evaluation of radiolucent lines progression
Measured: 5 years, 10 years
Record of adverse events
Measured: 1, 5 years and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study startOct 2013
- Primary completion31 Dec 2022
- Study completionAug 2025
Why it stopped: impossibility to carry on the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Replacement ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505580
- Sponsor's protocol ID
- P01.001.07
- Status last verified
- Sep 2025
- First submitted
- 16 Apr 2018
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude rétrospective et Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la sécurité de l'Implant AMIStem
- ClinicalTrials.gov ID
- NCT03505580
- Acronym / sponsor ID
- P01.001.07
- Conditions
- Hip Replacement Arthroplasty
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: impossibility to carry on the study
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medacta International SAIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- Aug 2025 (actual)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate radiological performance of the cementless femoral stem AMIStem H at 1 and 5-year follow-up.
All the patients operated at the investigational sites between April 2009 and April 2012 will be reviewed at 1, 5 and 10 year according to standard practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All the patients who undewent total hip arthroplasty with AMIStem-H cementless femoral stem at the investigational sites between April 2009 and April 2012
Key inclusion criteria (2 listed)
- patients who underwent total hip arthroplasty at the investigational sites between April 2009 and April 2012
- patients bearing an AMIStem-H cementless femoral stem
Key exclusion criteria (1 listed)
- patients who refuse to give consent for the treatment of data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of radiolucencies
Time frame: 5 years
4 secondary outcomes
correlation between the presence of radiolucencies and patient/implant characteristics
Time frame: 5 years, 10 years
evaluation of radiolucent lines progression
Time frame: 1 years, 10 years
evaluation of radiolucent lines progression
Time frame: 5 years, 10 years
Record of adverse events
Time frame: 1, 5 years and 10 years
Results and safety
The study was stopped early (reason given: impossibility to carry on the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Replacement Arthroplasty, run by Medacta International SA at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: impossibility to carry on the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of radiolucencies (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.